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Unapproved Stem Cell Therapies Pose Patient Risks

A recent study found that more than 350 businesses are marketing stem cell procedures at clinics across the country, despite the fact that the therapies are not approved by the U.S. Food and Drug Administration (FDA). More than 100 clinics were located in California.

Stem cells, which are found in embryos, umbilical cord blood, and adult bone marrow, hold great promise for the treatment of many diseases and medical conditions because they can develop into any type of specialized cell in the body. However, unapproved stem cell therapies pose risks to patients because they are often not supported by conclusive evidence regarding their safety or effectiveness.

As Reuters reports, stem cell procedures must generally be approved by the FDA prior to being marketed to the public, and the agency has granted only one such approval. Nonetheless, a recent study found that 351 companies are marketing unapproved stem cell procedures at more than 570 clinics across the United States. Many advertise claims related to ALS, Alzheimer’s disease, Parkinson’s disease, and many other conditions for which there is no established scientific consensus that stem cell treatments are safe and effective.

“Many of these marketing claims raise significant ethical issues given the lack of peer-reviewed evidence that advertised stem cell interventions are safe and efficacious for the treatment of particular diseases,” the researchers wrote.

It is not surprising that patients turn to the Internet in search for treatment, particularly if traditional medicine has been unsuccessful. However, as San Diego medical malpractice attorneys, we are concerned that unapproved stem cell procedures can lead to physical, emotional, and financial harm to patients who are already ill or injured.

The FDA is currently working on updated guidelines for stem cell procedures. In the meantime, the agency advises: “If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.”

If you or someone you care about has suffered serious harm due to a dangerous or defective drug or medical device, don’t hesitate to contact a San Diego injury lawyer at the Law Offices of Robert Vaage for a free consultation. Our legal team has successfully represented clients against manufacturers and distributors of medical devices for more than 30 years.